NCT01896635

Faecal Microbiota Transplantation in Ulcerative Colitis

Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: The University of New South Wales · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial

Detailed description

This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
BIOLOGICAL	FMT infusions	Active FMT derived from healthy anonymous pre-screened donors
OTHER	Placebo infusion	Placebo infusion not containing any donor microbial material

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-11-01
• Completion: 2016-08-01
• First posted: 2013-07-11
• Last updated: 2016-10-25

Locations

3 sites across 1 country: Australia